The Trans Tasman Radiation Oncology Group (TROG) has been commissioned by the Department of Health and Ageing to undertake a project to assess new Radiation Oncology Technology and Treatments. This project is being undertaken in response to a recognised need for the Medicare Benefits Schedule to support appropriate new radiation oncology technologies and treatments as they become available, to ensure optimal patient care.

The first phase of the project required TROG to develop a Generic Research Framework (the Framework) capable of collecting and generating information to substantiate the safety, clinical efficacy and cost effectiveness of new technologies and treatments.

The second (and current) phase of the project requires that the Framework be piloted to assess the safety, clinical efficacy and cost effectiveness of Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT) in four tumour site specific regions:

The aims of the site specific components of the ANROTAT protocol are as follows:

Protocol A. Develop an approach for applying the Framework to evaluate the safety, clinical efficacy and cost-effectiveness of IMRT compared to 3DCRT in patients with prostate cancer (PP).

Protocol B. Develop an approach for applying the Framework to evaluate the safety, clinical efficacy and cost-effectiveness of IMRT compared to 3DCRT in AC.

Protocol C. Develop an approach for applying the Framework to evaluate the safety, clinical efficacy and cost-effectiveness of IMRT compared to 3DCRT in NPC.

Protocol D. Develop an approach for applying the Framework to evaluate the safety, clinical efficacy and cost-effectiveness of IGRT compared to non-IGRT in patients with intermediate risk prostate cancer.

Tumour control estimated from surrogate physical dose endpoints with each of the new technologies as compared with standard therapy.

The likelihood of acute or long term damage to organ/tissue and resultant likelihood of impairment of function or QoL estimated from surrogate physical dose endpoints with each of the new technologies as compared with standard therapy.

Obtain Data on the impact of disease and treatment on QoL [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Measured by

QALYs gained, and cost-per-QALY gained

The likely cost increases or savings resulting from differences in acute or long term toxicity.

Compare the resource usage associated with the planning and delivery of the new technologies compared to the conventional standard approaches [ Time Frame: 6 months ] [ Designated as safety issue: No ]

The differences in time and resources required for preparation, planning, quality assurance (QA) checking and treatment for each of the new technologies as compared with standard therapy.

The likely cost increases or savings associated with differences in time and resources involved in the management of patients with each of the new technologies as compared with standard therapy.

Synthesise the data obtained for objectives 1-3 together with information from previous studies and expert opinion to estimate the safety, clinical efficacy and cost-effectiveness of new technologies compared to conventional standards [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

- A sample of 30 patients from at least 10 centres that are to be treated for intermediate risk prostate cancer will be enrolled. The sample will be selected to comprise at least 10 patients that will undergo non-IGRT, 10 that will undergo IGRT with fiducials and planar imaging, and 10 that will undergo IGRT with volumetric imaging.

Adequate staging of local disease (MRI of primary must be performed, imaging of neck nodes with CT with contrast and/or PET-CT) and exclusion of distant metastatic disease (to be confirmed by either whole body PET-CT or a chest CT, and upper abdominal CT or ultrasound scan for patients with abnormal liver function tests or a bone scan or FDG-PET for patients with bone pain).

Disease must be considered potentially curable by chemoradiation

Patients must be medically fit for cisplatin chemotherapy according to local practice (adequate renal, cardiac function, no significant neurological co-morbidities)

Previous therapy for carcinoma of the prostate other than biopsy or transurethral resection.

Previous pelvic RT or surgery (eg abdomino-perineal resection)

Hip prosthesis

Inflammatory bowel disease

Previous or current use of AD

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01379872